Original New Drug Application Approvals by US FDA (16-31 October 2023)

08 Nov 2023
Original New Drug Application Approvals by US FDA (16-31 October 2023)
New drug applications approved by US FDA as of 16-31 October 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

XPHOZAH
  • Active Ingredient(s): Tenapanor Hydrochloride
  • Strength: 10MG, 20MG, 30MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Ardelyx Inc
  • Approval Date: 17 October 2023
  • Submission Classification: NA
  • Indication(s): Indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
  • Approved Label:  17 October 2023 (PDF)
COMBOGESIC IV
  • Active Ingredient(s): Acetaminophen And Ibuprofen
  • Strength: 10MG, 300MG, 1000MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: AFT Pharms Ltd
  • Approval Date: 17 October 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults where an intravenous route of administration is considered clinically necessary for:
    • the relief of mild to moderate pain
    • the management of moderate to severe pain as an adjunct to opioid analgesics

    Limitations of Use
    COMBOGESIC IV is indicated for short-term use of five days or less.
  • Approved Label:  17 October 2023 (PDF)
ZILBRYSQ
  • Active Ingredient(s): Zilucoplan Sodium
  • Strength: 16.6MG/0.416ML, 23MG/0.574ML, 32.4MG/0.81ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: UCB INC
  • Approval Date:17 October 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are antiacetylcholine receptor (AChR) antibody positive.
  • Approved Label:  17 October 2023 (PDF)
QLOSI
  • Active Ingredient(s): Pilocarpine Hydrochloride
  • Strength: 0.4%
  • Dosage Form(s) / Route(s): Solution;ophthalmic
  • Company: Orasis Pharmaceuticals, Ltd.
  • Approval Date: 17 October 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of presbyopia in adults.
  • Approved Label:  17 October 2023 (PDF)
BIMZELX
  • Active Ingredient(s): Bimekizumab-bkzx
  • Strength: 160ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: UCB INC
  • Approval Date:17 October 2023
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or photo therapy. 
  • Approved Label:  17 October 2023 (PDF)
ZITUVIO
  • Active Ingredient(s): Sitagliptin
  • Strength: 25MG, 50MG, 100MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Zydus Worldwide Dmcc
  • Approval Date:18 October 2023
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    • Limitations of Use :
    ZITUVIO is not recommended in patients with type 1 diabetes mellitus
    ZITUVIO has not been studied in patients with a history of pancreatitis
  • Approved Label:  18 October 2023 (PDF)
CABTREO
  • Active Ingredient(s): Clindamycin Phosphate, Adapalene, And Benzoyl Peroxide
  • Strength: 1.2%;0.15%;3.1%
  • Dosage Form(s) / Route(s): Gel;topical
  • Company: Bausch Health Us, Llc
  • Approval Date:20 October 2023
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
  • Approved Label:  20 October 2023 (PDF)
COXANTO
  • Active Ingredient(s): Oxaprozin
  • Strength: 300MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Solubiomix, Llc
  • Approval Date:20 October 2023
  • Submission Classification: Not Available
  • Indication(s): Indicated for:
    • Relief of signs and symptoms of Osteoarthritis (OA)
    • Relief of signs and symptoms of Rheumatoid Arthritis (RA)
    • Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA)
  • Approved Label:  20 October 2023 (PDF)
ROZLYTREK
  • Active Ingredient(s): Entrectinib
  • Strength: 50MG
  • Dosage Form(s) / Route(s): Pellets;oral
  • Company: Genentech Inc
  • Approval Date: 20 October 2023
  • Submission Classification:Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
    • Adult and pediatric patients older than 1 month of age with solid tumors that:
      o have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation,
      o are metastatic or where surgical resection is likely to result in severe morbidity, and
      o have progressed following treatment or have no satisfactory alternative therapy.

      • This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • Approved Label:  20 October 2023 (PDF)
ZYMFENTRA
  • Active Ingredient(s): Infliximab-dyyb
  • Strength: 120MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Celltrion
  • Approval Date: 20 October 2023
  • Submission Classification: Not Available
  • Indication(s): Indicated in adults for maintenance treatment of:
    • moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
    • moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously. 
  • Approved Label:  20 October 2023 (PDF)
AGAMREE
  • Active Ingredient(s): Vamorolone
  • Strength: 40MG/ML
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Santhera Pharma
  • Approval Date: 26 October 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
  • Approved Label:  26 October 2023 (PDF)
OMVOH
  • Active Ingredient(s): Mirikizumab-mrkz
  • Strength: 300MG/15ML,100MG/ML
  • Dosage Form(s) / Route(s): Vial; Single-use, Injectable;subcutaneous
  • Company: Eli Lilly And Co
  • Approval Date: 26 October 2023
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of moderately to severely active ulcerative colitis in adults.
  • Approved Label:  26 October 2023 (PDF)
 LOQTORZI
  • Active Ingredient(s): Toripalimab-tpzi 
  • Strength: 240MG/6ML(40MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Coherus Biosciences Inc
  • Approval Date: 27 October 2023
  • Submission Classification: Not Available
  • Indication(s): Indicated:
    • in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC).
    • as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
  • Approved Label:  27 October 2023 (PDF)
WEZLANA
  • Active Ingredient(s): Ustekinumab-auub
  • Strength: 45MG/0.5ML, 90MG/ML, 130MG/26ML
  • Dosage Form(s) / Route(s): Injectable;intravenous, Subcutaneous
  • Company: Amgen Inc
  • Approval Date:31 October 2023
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of:

    • Adult patients with:
    • moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy.
    • active psoriatic arthritis (PsA).
    • moderately to severely active Crohn’s disease (CD).
    • moderately to severely active ulcerative colitis.

    Pediatric patients 6 years and older with:
    • moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
    • active psoriatic arthritis (PsA).
  • Approved Label:  31 October 2023 (PDF)